The law giving the Food and Drug Administration (FDA) authority to regulate tobacco products requires that it base decisions on science, including proposals to reduce the harm caused to those who smoke and to discourage youngsters from using tobacco.

Leading this ambitious effort is David Ashley, the science director of the FDA’s Center’s for Tobacco Products, who sees his job as “an incredible opportunity to have an impact on public health.”

“With over 400,000 Americans dying every year from smoking, tobacco use is the greatest preventable cause of disease and death in the United States,” said Ashley. “We have a critical mission because we help provide the science that supports the guidance and regulations, and assists in the review new product applications.”

“If we do our job well, we will largely end the tragedy that results from tobacco use and people will no longer have to suffer a painful, agonizing death years before they should,” said Ashley.

President Barack Obama signed into law the Family Smoking Prevention and Tobacco Control Act in June 2009, granting the FDA authority to regulate the manufacture, marketing and distribution of tobacco products to protect public health and to reduce tobacco use by minors.

( Photo: Centers for Disease Control and Prevention )

Ashley was appointed to his science position a year later after spending 27 years at the Centers for Disease Control and Prevention (CDC), where he directed scientists who examined the public health effects of heavy metals, organic compounds, and how tobacco product ingredients and additives impact the diseases that result from their use.

Ashley said he has spent the past two years hiring a staff of about 70 people, “getting our feet on the ground,” establishing the research agenda, and building relationships with outside organizations like the National Institutes of Health that will conduct the scientific inquiries.

He said some of the top priorities for research include looking at ways to reduce addiction to tobacco products; reducing the toxicity and carcinogenicity of tobacco products and smoke; understanding the adverse health consequences of tobacco use; and better understanding communications and marketing regarding tobacco products.

Ashley said the science agenda as well as the work of the entire tobacco regulatory center has been steadily making progress. However, he said one of the frustrations is that decisions are not made as fast as he would like.

“There are good reasons for that,” said Ashley. “We need to get input from many different stakeholders in order that the decisions we make will be the most appropriate and most effective.”

Nevertheless, Ashley said that it is “a challenge to know that for every day a decision is delayed and we cannot act, about 1200 people die from using tobacco products.”

Kim Elliott, the associate director at the FDA’s Center for Tobacco Products, said Ashley is “a world renowned chemist who has tremendous expertise on tobacco product design and what goes into the products.”

“His knowledge has been essential in building the FDA’s regulatory science foundation for tobacco,” said Elliott. “His leadership and vision are essential for the FDA to achieve its crucial new mission. He has brought together some of the best scientists in the country on tobacco.”

Ashley, who commutes every week from an Atlanta suburb to his FDA office in Maryland, said he was motivated to pursue a career in science and public health as a teenager when his mother was diagnosed with colon cancer, and then died a few years later.

“I had the desire to do something that would make a big difference in people’s lives and their health, even if I couldn’t help her,” said Ashley. “Working at CDC and FDA has given me that opportunity. That’s what continues to get me to work every morning and keeps me going every day.”

This article was jointly prepared by the Partnership for Public Service, a group seeking to enhance the performance of the federal government, and Go to to read about other federal workers who are making a difference.